510(k) K033200 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
ARIOL
| Applicant | Applied Imaging Corp., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Oct 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | Leica Biosystems Richmond Inc. Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of Terminated |
NQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.